REVA Medical, Inc. (ASX:RVA) is pleased to provide the attached Appendix 4C Quarterly Report for the quarter ended 30 September 2016. The Appendix 4C is unaudited.
Third Quarter Highlights
The Company completed an application for CE Marking of its Fantom scaffold in August 2016, continues to collect data from its clinical trials, and is preparing for commercialization. Fantom is a bioresorbable drug-eluting scaffold that utilizes REVA’s advanced proprietary polymer to allow thinner strut thickness and enhanced deliverability, while offering its unique property of being visible under x-ray.
During the first quarter of 2016, the Company completed enrollment of the FANTOM II clinical trial with a total of 240 patients enrolled. During the second quarter of 2016, the Company completed the primary endpoint of an imaging assessment at a six-month time point on patients in Cohort A of the trial and released positive data from those patients. During the third quarter of 2016, the Company achieved the following:
Finalized data analyses on patients in the FANTOM II clinical trial through the six-month primary endpoint and completed the application for regulatory approval to commercialize under the CE Mark in Europe. The endpoint data was obtained from the 117 patients in Cohort A of the trial and showed favorable results, including a Major Adverse Cardiac Events rate of 2.56% and a Late Lumen Loss of 0.25mm (±0.40mm) in scaffold and 0.17mm (±0.34mm) in segment. Low late loss is a desirable result that historically corresponds to positive long-term outcomes; permanent drug-eluting stents and competitive bioresorbable scaffolds generally have late loss values in the range of 0.20mm to 0.40mm.
Initiated primary nine-month endpoint assessments on the remaining 123 patients enrolled in trial and began analyzing and compiling that data. Patients are scheduled to complete the nine-month imaging assessments in January 2017.,
Continued to prepare manufacturing operations for commercialization, which includes refining the processes, conducting verification on the processes, and other commercial preparation aspects for Fantom..
Successfully completed the first of two on-site audits required for the CE Marking process in August, with no audit findings. The independent notified body conducted the second on-site audit this week and results are pending. In addition to these audits, the Company expects to receive the initial response to the data and other documentation submitted with the application by early December, with the possibility of receiving CE Mark by year end.
Continued to identify and pursue sources of follow-on financing to secure additional capital. In addition to evaluating these options, the Company continues to support its plan to pursue a listing of its securities on NASDAQ or another U.S. exchange no later than 30 June 2017.
Appendix 4C
As of 30 September 2016, the Company’s cash balance was US$11,553,000. The current quarter end cash balance reflects a decrease of US$4,996,000 from the 30 June 2016 balance of US$16,549,000. This decrease reflects US$4,742,000 in disbursements related to normal operating activities and capital equipment purchases of US$254,000.
The Company currently plans to file its Form 10-Q Quarterly Report with the U.S. Securities and Exchange Commission and with the Australian Securities Exchange on or before the due date of 10 November 2016. The Quarterly Report provides financial statements, along with Management’s Discussion and Analysis of Financial Condition and Results of Operations for the quarter ended 30 September 2016.
About REVA
REVA is a clinical stage medical device company located in San Diego, California, USA, that is working to commercialize its proprietary bioresorbable scaffolds, as an alternative to metal stents, to treat coronary artery disease. Scaffolds provide restoration of blood flow, support the artery through the healing process, then disappear (or “resorb”) from the body over a period of time. This resorption allows the return of natural movement and function of the artery, a result not attainable with permanent metal stents. The Company’s Fantom® scaffold has been designed to offer an ideal balance of thinness and strength, with distinct ease-of-use features including complete scaffold visibility under x-ray, expansion with one continuous inflation, and no procedural time limitations. REVA will require regulatory approval before it can commercialize Fantom or any other product.
